Pivotal trial

Check-Cap Provides Update on COVID-19 Pandemic Impact on Operational and Clinical Activities

Retrieved on: 
Monday, April 6, 2020
Articles, Health, Coronaviridae, Clinical research, Clinical trials, Animal virology, Coronavirus, Forward-looking statement, Pivotal trial, Clinical, Pandemic

Also, Check-Cap has temporarily suspended interactions between hospitals and healthcare professionals and its employees and clinical trial patients.

Key Points: 
  • Also, Check-Cap has temporarily suspended interactions between hospitals and healthcare professionals and its employees and clinical trial patients.
  • Consequently, though it is difficult to predict the impact of the coronavirus pandemic on the clinical timeline, the commencement of the pivotal trial is now expected to be pushed into 2021.
  • We are assessing the situation as it develops and plan to provide an update on timing when we have more clarity."
  • The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

"American Journal of Sports Medicine" publishes results of an FDA-approved clinical trial for treating osteoarthritis knee pain

Retrieved on: 
Monday, March 2, 2020
Health, Articles, Drug discovery, Arthritis, Osteoarthritis, RTT, Food and Drug Administration, Pivotal trial, Therapy

The cellular therapy for osteoarthritis procedure showed no serious adverse events at two years and a significant reduction in pain at one year.

Key Points: 
  • The cellular therapy for osteoarthritis procedure showed no serious adverse events at two years and a significant reduction in pain at one year.
  • A Phase III pivotal study begins soon at Tulane University School of Medicine with additional trial sites participating nationwide.
  • We've completed a prior safety trial, an FDA-approved Phase IIb trial, and are now beginning a Phase III pivotal trial.
  • The journal acts as an important forum for independent orthopaedic sports medicine research and education, allowing clinical practitioners the ability to make decisions based on sound scientific information.

Valencia Technologies Announces Interim Efficacy Data from eCoin® Pivotal Trial

Retrieved on: 
Monday, March 2, 2020
Health, Clinical research, Clinical trials, Medical research, Food and Drug Administration, Medical statistics, Pharmaceutical industry, Pivotal trial

VALENCIA, Calif., March 2, 2020 /PRNewswire/ --Valencia Technologies Corporation ("Valencia"), a private medical device company, today announced 6-month interim efficacy data from its eCoin Pivotal Clinical Trial.

Key Points: 
  • VALENCIA, Calif., March 2, 2020 /PRNewswire/ --Valencia Technologies Corporation ("Valencia"), a private medical device company, today announced 6-month interim efficacy data from its eCoin Pivotal Clinical Trial.
  • All available data was presented and the protocol did not include a trial of the therapy prior to eCoin implantation.
  • Scott A. MacDiarmid, MD, an investigator in the trial, commented, "We are extremely encouraged by this early data and I continue to believe in the paradigm shifting potential of eCoin.
  • Jeff Greiner, Chief Executive Officer of Valencia, stated, "We were excited to have Dr. Rogers present interim efficacy data from our pivotal trial at SUFU 2020.

IVERIC bio Announces Design for Second Pivotal Clinical Trial of Zimura® in Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Retrieved on: 
Monday, January 13, 2020
Pharmaceutical, Health, Clinical trials, Health, Medicine, Geographic atrophy, Macular degeneration, Pivotal trial, Clinical trial

IVERIC bio, Inc. (Nasdaq: ISEE) today announced the design of the second pivotal clinical trial for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Key Points: 
  • IVERIC bio, Inc. (Nasdaq: ISEE) today announced the design of the second pivotal clinical trial for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
  • This second pivotal trial will be an international, multicenter, double masked, sham controlled clinical trial.
  • Based on the positive 12-month results from our first pivotal trial for Zimura in GA we are looking forward to enrolling our first patient in our second pivotal clinical trial, stated Kourous A. Rezaei, M.D., Chief Medical Officer of IVERIC bio.
  • IVERIC bio provided further details supporting the positive results from this trial, which the Company plans to use as a pivotal trial, in its Quarterly Report on Form 10-Q filed on November 12, 2019.

Citius Reaches First Interim Analysis Milestone for Mino-Lok® Pivotal Trial

Retrieved on: 
Monday, October 7, 2019
Health, Clinical research, Medical research, Clinical pharmacology, Clinical trial, Design of experiments, Pharmaceutical industry, Pivotal trial

The Company is preparing the submission to the independent Drug Monitoring Committee ("DMC") for review and evaluation.

Key Points: 
  • The Company is preparing the submission to the independent Drug Monitoring Committee ("DMC") for review and evaluation.
  • The Mino-Lok protocol is based on reaching 92 catheter failure events for the trial, which corresponds to approximately 144 patients treated in both arms combined.
  • There are 2 interim analyses planned:
    "We are extremely pleased to have reached this important milestone in the pivotal trial.
  • We believe that this pivotal trial will be the largest and best controlled clinical trial evaluating catheter salvage in diagnosed CLABSI patients to date.

Mereo BioPharma Announces Interim Financial Results for the Six Months Ended June 30, 2019 and Provides Corporate Update

Retrieved on: 
Tuesday, September 17, 2019
Pivotal trial, Monoclonal antibodies

In May 2019, Mereo reported positive 6-month interim data from the fully-enrolled ASTEROID study.

Key Points: 
  • In May 2019, Mereo reported positive 6-month interim data from the fully-enrolled ASTEROID study.
  • The Company expects to report 12-month topline data from the blinded portion of the study in Q4 2019.
  • If the results are positive, Mereo intends to commence a pivotal trial in the EU and the U.S. in AATD as soon as possible therafter.
  • In April 2019, Mereo completed a merger with OncoMed Pharmaceuticals, Inc. (OncoMed), acquiring two clinical stage oncology programs - navicixizumab and etigilimab.

Retrotope Announces Full Enrollment of Phase 2/3 trial in patients with Infantile Neuroaxonal Dystrophy (INAD)

Retrieved on: 
Wednesday, August 7, 2019
Health, Retrotope, Chemistry, Food and Drug Administration, Di-deuterated linoleic acid ethyl ester, Pharmaceutical industry, Clinical research, Design of experiments, Clinical trial, Pivotal trial

The U.S. Food and Drug Administration (FDA) has granted the company approval to conduct this trial as an open-label Phase 2/3 clinical trial in 15-20 patients.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has granted the company approval to conduct this trial as an open-label Phase 2/3 clinical trial in 15-20 patients.
  • Retrotope previously enrolled two INAD patients in individual Expanded Access trials, the first patient of which has been on drug over 2 years.
  • The Phase 2/3 clinical trial is an important milestone in the development pathway of RT001 commented Harry J, Saal, Executive Chairman of Retrotope.
  • RT001, Retrotopes first lead candidate, is being tested in a phase 2/3 study in INAD with plans for a pivotal trial in FA.

GI Dynamics Announces Institutional Review Board Approval for EndoBarrier Pivotal Trial

Retrieved on: 
Thursday, February 14, 2019
Health, Biotechnology, Clinical trials, Medical devices, Pharmaceutical, Diabetes, Health, Food and Drug Administration, United States Public Health Service, Pivotal trial, Medical research, Pharmaceutical industry, Clinical research

GI Dynamics Inc. (ASX:GID), a medical device company that is developing EndoBarrier for patients with type 2 diabetes and obesity, is pleased to announce that it has received Institutional Review Board (IRB) approval to conduct its pivotal trial of EndoBarrier for type 2 diabetes and obesity.

Key Points: 
  • GI Dynamics Inc. (ASX:GID), a medical device company that is developing EndoBarrier for patients with type 2 diabetes and obesity, is pleased to announce that it has received Institutional Review Board (IRB) approval to conduct its pivotal trial of EndoBarrier for type 2 diabetes and obesity.
  • IRB approval is required by the FDA and is an essential step to allow the EndoBarrier pivotal trial to proceed.
  • GI Dynamics was notified today that the following EndoBarrier pivotal trial documentation is approved by WIRB: protocol, informed consent form, and investigators brochure.
  • When we announced that the FDA approved our Investigational Device Exemption (IDE) for the pivotal trial of EndoBarrier, the approval was conditional upon IRB approval, said Scott Schorer, president and chief executive officer of GI Dynamics.